Device recall
Z-0639-05: Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060…
FDA device recall · Class II · Boston Scientific
Key facts
| Recall number (Z-number) | Z-0639-05 |
|---|---|
| Recall event | 31230 |
| Product | Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075 |
| Product code | MTD |
| Recalling firm | Boston Scientific |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2005 |
| 510(k) numbers | K000277, K003782, K021232, K983171, K992777 |
| FEI number | 3001236349 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database